Brain–computer interface (BCI) company Precision Neuroscience has introduced two new clinical study sites in the US to expand the clinical research of its Layer 7 Cortical Interface BCI technology.

The Mount Sinai Health System and Perelman School of Medicine at the University of Pennsylvania (Penn Medicine) sites will help understand how the brain regulates movement and help people with neurological conditions.

Layer 7 Cortical Interface is Precision Neuroscience’s brain implant with an electrode array made up of 1,024 miniature electrodes present across 1.5cm2.

The technology is designed to record neural activity in real-time at resolutions hundreds of times more detailed than conventional cortical surface arrays used in neurosurgical procedures.

Precision Neuroscience chief science officer and co-founder Ben Rapoport said: “Mount Sinai and Penn Medicine are major centers of excellence, known for spearheading advancements in neurotechnology,” Rapoport said.

“Each of our partners has focused on a unique area of applied neuroscience, and each study leverages the high resolution neural data produced by our arrays to shed light on a different aspect of how the brain works.”

At Mount Sinai, the BCI company seeks to study the diverse usages of high-resolution cortical surface arrays in clinical settings, extending from intraoperative monitoring to neurocritical care.

Under this open-label, single-arm feasibility study, the investigational device is being temporarily placed on the surface of study participants’ brains during intracranial procedures.

The device will record electrophysiological signals and compare the data to that acquired using standard-of-care cortical surface arrays.

The study’s secondary objective is to assess the thin-film electrode’s capacity to map electrophysiological correlates of awake behavioural tasks, such as motor, speech, and cognitive tasks.

At Penn Medicine, the clinical research will decode the neural signals underlying hand movement. The researchers will use the Layer 7 Cortical Interface with motion capture technology to understand the relation between the brain’s motor cortex with the rest of the body.

During the trial, the Layer 7 device will be implanted through the same burr hole used to deliver DBS electrodes in patients undergoing awake neurosurgery operations.

Following that, patients are fitted with motion capture gloves to record natural reach and grip kinematics of hand and arm movement.

Both studies are expected to recruit up to 15 patients every year.